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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020133
Receipt No. R000023258
Scientific Title Application of Mental Health First Aid to medical staff: Multicenter pilot study
Date of disclosure of the study information 2015/12/10
Last modified on 2020/06/12

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Basic information
Public title Application of Mental Health
First Aid to medical staff: Multicenter pilot study
Acronym Application of Mental Health
First Aid to medical staff
Scientific Title Application of Mental Health
First Aid to medical staff: Multicenter pilot study
Scientific Title:Acronym Application of Mental Health
First Aid to medical staff
Region
Japan

Condition
Condition Depression and suicide related behaviors
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of a brief structured training program based on Mental Health First Aid to increase knowledge and skills for medical staff, institutional staff and employees (including managers) to deal with person with depression and suicidal thoughts.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change of score of questionnaire asking knowledge, skills and confidence to deal with person with depression and suicidal thoughts at just before, just after and one month later the intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Mental Health First Aid (MHFA) program including lecture and role playing
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Medical staff, welfare service worker, non-medical staff such as student counseling center, company, students majoring in medicine, dentistry, pharmacy, or science of jnursing, and so on, given written informed consents on this study
Key exclusion criteria None
Target sample size 350

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name A
Last name Kato
Organization Kyushu University
Division name Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL 092-642-5627
Email takahiro@npsych.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Kato
Organization Kyushu University
Division name Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL 092-642-5627
Homepage URL
Email takahiro@npsych.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Grant for clinical cancer research from
the Ministry of Health, Labour and
Welfare, Japan (Japan Agency for Medical Research and Development: AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University Hospital IRB
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
Tel 092-642-5082
Email byssien@jimu.kyushu-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院(福岡県)、岩手医科大学附属病院(岩手県)、慶応義塾大学病院(東京都)、北海道大学病院(北海道)、北海道大学保健センター(北海道)、横浜市立大学附属病院(神奈川県)、北九州市精神保健福祉センター(福岡県)、京都大学医学部附属病院(京都府)、飯塚病院(福岡県)、帝京大学(東京都)、城西国際大学(千葉県)、非医療機関(企業等)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
2019 Year 03 Month 18 Day
Anticipated trial start date
2015 Year 12 Month 18 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 09 Day
Last modified on
2020 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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